Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors

NCT07657611 | Not Yet Recruiting Early Phase 1

• 1 other identifier: NCC6293
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label phase I master platform study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of multiple inhaled in-vivo mRNA immunotherapies in adult patients with advanced solid tumors. Subjects will receive inhalation mRNA formulations at ascending dose levels following a 3+3 dose-escalation design to determine maximum tolerated dose and recommended phase II dose.

Conditions

Neoplasms; Solid Tumors; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  The primary endpoint is to assess the safety and tolerability of inhaled mRNA immunotherapy, including the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs).

  From the first dose of study treatment up to 30 days after the last dose.

Secondary Outcomes (1)

• Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D)

  Up to 28 days after the last dose in each dose cohort.

Study Arms (1)

Inhaled mRNA Immunotherapy

EXPERIMENTAL

All enrolled subjects will receive inhaled mRNA immunotherapy via Breezhaler dry powder inhaler. * Intervention 1: BMD007-T1 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter. * Intervention 2: BMD014-T5 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter. * Intervention 3: BMD013-T3 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter. Dose escalation will follow a standard 3+3 design. Treatment duration will not exceed 52 weeks.

Biological: Inhaled mRNA

Interventions

Inhaled mRNA BIOLOGICAL

Inhaled mRNA dry powder formulation, administered via a low-resistance dry powder inhaler.

Inhaled mRNA Immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥ 18 years.
• Confirmed diagnosis of advanced lung cancer (driver gene negative or targeted therapy failed) or pulmonary metastatic solid tumors, with no standard treatment options available or who have failed prior standard therapies.
• Presence of at least one measurable lesion according to RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function, including hematologic, hepatic, and renal function.
• Ability to understand and sign the informed consent form.
• Expected survival of at least 12 weeks.

You may not qualify if:

• History of severe hypersensitivity to mRNA-based therapies or components of the study drug.
• Uncontrolled active infection or severe underlying respiratory disease (e.g., severe COPD, asthma requiring high-dose steroids).
• Prior allogeneic stem cell or solid organ transplantation.
• Current use of other investigational agents within 4 weeks before the first dose of study treatment.
• Active autoimmune disease requiring systemic immunosuppressive therapy.
• Pregnant or breastfeeding women.
• Any condition that, in the investigator's opinion, would interfere with study compliance or safety.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label study, no blinding implemented.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm open-label phase I trial with standard 3+3 dose-escalation design for multiple inhaled mRNA immunotherapy agents.

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 18, 2026

Record last verified: 2026-06